NCT02204839已完成不适用
The Metabolic and Glycaemic Effects of a Combined Basal-Bolus Insulin Reduction And Carbohydrate Feeding Strategy For Evening Exercise in Type 1 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 24 hour blood glucose area under the curve
研究概览
简要总结
The investigators hypothesise that reducing basal insulin dose (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk), whilst employing current carbohydrate feeding and rapid-acting insulin dose recommendations will protect patients with type 1 diabetes from early- and late-onset hypoglycaemia following evening time exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Aged between 18-50 years old (male or female).
- •Free from any diabetes related complications (apart from mild background diabetic retinopathy).
- •HbA1c <8.5%.
- •Not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study.
- •Demonstrate normal cardiac function in response to exercise.
排除标准
- •Aged younger than 18, or older than 50 years.
- •Suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy).
- •HbA1c >8.5%.
- •Currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or determir, and lispro or aspart for at least 6 months before the start of the study.
- •Failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.
研究组 & 干预措施
Basal dose reduction
Experimental
Total daily basal (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk) reduction of 20% versus normal basal dose.
干预措施: Basal insulin dose (Drug)
结局指标
主要结局
24 hour blood glucose area under the curve
时间窗: 24 hours
24 hour blood glucose area under the curve
次要结局
- Ketonaemia(60 minutes before and 24 hours post-exercise)
研究者
研究点 (1)
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